Table 2. Results for Components of Composite Functional End Point and Magnetic Resonance Imaging (MRI) End Point.
| Finding | No. (%) | Unadjusted Estimated Effect of Venous PTA, OR (95% CI) | P Value | Adjusted P Valuea | |
|---|---|---|---|---|---|
| PTA (n = 73) | Sham (n = 37) | ||||
| Composite functional end pointb | |||||
| Improved | 30 (42) | 18 (49) | 0.75 (0.34-1.68)c | .49 | NA |
| Stable | 17 (24) | 8 (22) | NA | ||
| Worsened | 9 (13) | 7 (19) | NA | ||
| Mixed | 16 (22) | 4 (11) | NA | ||
| MRI end point (new combined lesions)d | |||||
| No. of lesions, mean (SD) | 1.40 (4.21) | 1.95 (3.73) | 0.72 (0.32-1.63)e | .45 | .45 |
| Median (range) | 0 (0-31) | 1 (0-8) | NA | NA | NA |
| No. patients free of new lesions | 46 (63) | 18 (49) | 1.80 (0.81-4.01)f | .15 | .30 |
Abbreviations: NA, not applicable; OR, odds ratio; PTA, percutaneous transluminal angioplasty.
a
P values adjusted for multiplicity with Hommel method.
b
Seventy-two patients in the PTA group had composite functional end point data.
c
OR for PTA group improvement with 95% CI and P value from logistic model.
d
New combined lesions include new lesions on T2-weighted images, preexisting lesions enlarged by >30% on T2-weighted images, and gadolinium-enhancing lesions in T1-weighted images of preexisting lesions (no enlarged T2 lesions were observed).
e
Mean lesion ratio with 95% CI and P value from negative-binomial model.
f
OR of being lesion free with 95% CI and P value from χ2 test.